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This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.
Full description
This is a non-randomised, single arm, open-label study of Cybis™ 10:25 in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.
The purpose of the study is to demonstrate the safety and tolerability of Cybis™ 10:25 in participants with moderate to severe chronic back or neck pain that is unresponsive to over-the-counter non-opioid analgesics.
Participants will undergo a screening visit, then seven clinic visits (Day 1, 2, 8, 15, 22, 29, and 35). Cybis™ 10:25 will be administered oromucosally at doses varying from 0.5 mL once daily to 1.5 mL twice daily. Total duration of dosing is 28 days.
Enrollment
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Inclusion criteria
Exclusion criteria
Are pregnant or breastfeeding;
Currently using marijuana or other medicinal cannabis products; Use of medical cannabis products > 6 months prior to Screening is acceptable;
History of cannabis use disorder (score of 8 or higher on The Cannabis Use Disorder Identification Test - Revised (CUDIT-R);
Current or previous allergies or allergic responses to any of the components of the study treatment (e.g., THC, CBD, MCT);
Current or previous allergies or allergic responses to any of the components of the rescue medication (e.g. paracetamol, ibuprofen, aspirin, other NSAIDs);
Significant cardiac disease (e.g. poorly controlled hypertension, symptomatic ischaemic heart disease, symptomatic heart failure);
Chronic liver disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper level or normal limits;
Chronic renal impairment with eGFR <30mL/min;
Taking sildenafil or other PDE5 inhibitors;
Being treated with known inducers/inhibitors of CYP3A4, in particular clarithromycin, rifampicin, azole antifungals, antiretroviral agents, anticonvulsants (phenytoin, carbamazepine), SSRI within 30 days of study commencement; Use of such enzyme-altering agents is prohibited throughout the study.
Have a major psychiatric disorder (e.g. schizophrenia, psychosis, bipolar disorder, but not anxiety or depression), by history or examination;
Are currently using any illicit drug (including, but not limited to, amphetamines, cocaine);
Have a history of other substance abuse disorder (as defined by DSM-5);
Have active substance abuse disorder (alcohol, illicit drugs);
Other clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, or vital signs, which in the opinion of the Investigator, may put the participant at risk of adverse events;
Other chronic disease (other than chronic pain) that in the opinion of the Investigator may impact the safety, efficacy and/or pharmacokinetics of the study drug;
Are currently participating in, or have participated (in the last 30 days) in a drug or device clinical trial;
Currently using opioids (including but not limited to paracetamol+codeine combinations, codeine, tramadol, tapentadol, buprenorphine) and not willing to cease opioids for the duration of the study;
COVID-19 vaccination within two (2) weeks of study assessments:
Back and/or neck surgery within three (3) months of Screening; or
Have history of metastatic cancer or are currently receiving treatment for cancer.
Primary purpose
Allocation
Interventional model
Masking
28 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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